Status:
COMPLETED
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
Up to 23 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with ...
Detailed Description
Oseltamivir is approved for prophylaxis and treatment of children 1 year of age and older with influenza. Influenza treatments for children under the age of 1 year are needed because mortality from in...
Eligibility Criteria
Inclusion
- Signed informed consent from parent(s) or legal guardian(s).
- Age:
- Cohort I: 12 - 23 mo. Cohort II: 9 - 11 mo. Cohort III: 6 - 8 mo. Cohort IV: 3 - 5 mo. Cohort V: 0 - 2 mo.
- Confirmed laboratory diagnosis of influenza by viral culture or rapid influenza diagnostic test within 96 hours prior to study enrollment.
- Duration of influenza symptoms less than or equal to 96 hours.
Exclusion
- Concomitant vomiting illness that would preclude ability to take drug.
- Immunocompromised subject (e.g., malignancy, congenital agammaglobulinemia, HIV).
- Documented renal impairment (e.g., polycystic renal disease, nephrectomy, renal transplantation, renal agenesis, dialysis requirement, renal failure, nephrotic syndrome at any time prior to enrollment, current receipt of diuretic therapy).
- Documented hepatic impairment (e.g., congenital hepatitis, biliary atresia, cholelithiasis).
- Gastrointestinal abnormality which might hinder absorption of an oral medication.
- Current receipt of inotropic drugs (e.g., epinephrine, norepinephrine, dopamine, dobutamine).
- History of seizures.
- Documented congenital malformations of the central nervous system defined at birth (e.g., hydranencephaly, prosencephaly, spina bifida).
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00391768
Start Date
January 1 2007
End Date
April 1 2010
Last Update
May 1 2013
Active Locations (32)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35117
2
Arkansas Children's Hospital - Infectious Diseases
Little Rock, Arkansas, United States, 72202-3500
3
Miller Children's Hospital Long Beach - Bickerstaff Family Center
Long Beach, California, United States, 90806-1701
4
Children's Hospital of Orange County
Orange, California, United States, 92868-3835